Cefiderocol

Generic Name: Cefiderocol

Brand Names: Fetroja, Fetcroja

Drug Type: Small Molecule

Chemical Formula: C_₃₀H_₃₄ClN_₇O_₁₀S_₂

CAS Number: 1225208-94-5

Unique Ingredient Identifier: SZ34OMG6E8

Background: Cefiderocol is a cephalosporin antibacterial drug and exerts a mechanism of action similar to other β-lactam antibiotics. Unlike other agents in this category, cefiderocol is a siderophore able to undergo active transport into the bacterial cell through iron channels. It represents a significant addition to antibacterial treatment option as it has proven to be effective in vitro against multidrug resistant strains including extended spectrum β-lactamase producers and carbapenemase producing bacteria.

Cefiderocol was granted designation as a Qualified Infectious Disease Product and granted priority review status by the FDA on November 14, 2019. It is indicated for use in complicated urinary tract infections in patients with limited or no alternative treatments available. This indication was supported by a positive clinical trial composed of 448 patients with complicated urinary tract infections which demonstrated a 72.6% rate of symptom resolution and bacterial eradication with cefiderocol compared to 54.6% with the comparator, imipenem/cilastatin. A concern noted in the trial was a 0.3% higher rate of all cause mortality, the cause of which has not been determined.

Indication: Cefiderocol is indicated for the treatment of complicated urinary tract infections with or without pyelonephritis.

Associated Conditions: Complicated Urinary Tract Infection, Nosocomial Pneumonia, Pyelonephritis, Ventilator Associated Bacterial Pneumonia (VABP)

Associated Therapies: -

Clinical Trials

A DDI Study to Investigate PK and Safety of Cefiderocol in Combination With Xeruborbactam in Healthy Adult Participants

Phase 1

Not yet recruiting

Conditions: Bacterial Infections

Interventions: Drug: Dextrose 5% in water
Drug: Xeruborbactam
Drug: Cefiderocol
Drug: Xeruborbactam/Cefiderocol

First Posted Date: 2024-08-09

Last Posted Date: 2024-08-09

Lead Sponsor: Qpex Biopharma, Inc.

Target Recruit Count: 40

Registration Number: NCT06547554

Locations: 🇺🇸
Minneapolis Clinic, Minneapolis, Minnesota, United States

A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Cefiderocol in Hospitalized Neonates and Infants

Phase 2

Recruiting

Conditions: Gram-Negative Bacterial Infections

Interventions: Drug: Cefiderocol
Drug: Standard of Care

First Posted Date: 2023-10-17

Last Posted Date: 2024-06-05

Lead Sponsor: Shionogi

Target Recruit Count: 40

Registration Number: NCT06086626

Locations: 🇨🇳
Chang Gung Memorial Hospital, Linkou Department of Pediatrics, Taoyuan City, Taiwan
🇺🇸
Arkansas Children's Hospital, Little Rock, Arkansas, United States
🇿🇦
Tygerberg Hospital, Cape Town, Western Cape, South Africa

and more 1 locations

Cefiderocol and Ampicillin-sulbactam vs. Colistin +/- Meropenem for Carbapenem Resistant A. Baumannii

Phase 4

Not yet recruiting

Conditions: Carbapenem Resistant Bacterial Infection
Acinetobacter Bacteremia
Acinetobacter Pneumonia

Interventions: Drug: Cefiderocol
Drug: Colistin
Drug: Ampicillin-sulbactam
Drug: Meropenem

First Posted Date: 2023-06-28

Last Posted Date: 2024-04-16

Lead Sponsor: Rambam Health Care Campus

Target Recruit Count: 734

Registration Number: NCT05922124

Use of Cefiderocol in the Management of Gram-Negative Infections

Completed

Conditions: Gram-Negative Infection

Interventions: Drug: Cefiderocol

First Posted Date: 2023-03-29

Last Posted Date: 2023-06-26

Lead Sponsor: Shionogi

Target Recruit Count: 314

Registration Number: NCT05789199

Locations: 🇪🇸
Complejo Hospitalario Universitario de Albacete, Albacete, Spain
🇪🇸
Hospital Universitario Torrecardenas, Almeria, Almeria, Spain
🇪🇸
Hospital General Universitario Gregorio Marañón, Madrid, Spain

and more 52 locations

A Study to Assess the Effect of Cefiderocol on the Pharmacokinetics (PK) of Midazolam in Healthy Participants

Phase 1

Completed

Conditions: Healthy Volunteers

Interventions: Drug: Midazolam
Drug: Cefiderocol

First Posted Date: 2022-05-27

Last Posted Date: 2023-12-14

Lead Sponsor: Shionogi

Target Recruit Count: 14

Registration Number: NCT05395104

Locations: 🇺🇸
Worldwide Clinical Trials, San Antonio, Texas, United States

Cefiderocol Plasma Concentrations in Patients Receiving Renal Replacement Therapy

Phase 1

Completed

Conditions: Pharmacokinetics

Interventions: Drug: Cefiderocol

First Posted Date: 2022-05-13

Last Posted Date: 2024-12-18

Lead Sponsor: Hartford Hospital

Target Recruit Count: 14

Registration Number: NCT05373615

Locations: 🇺🇸
Hartford Hospital, Hartford, Connecticut, United States

Cefiderocol Pharmacokinetics in Adult Patients With Cystic Fibrosis

Phase 4

Completed

Conditions: Pneumonia, Bacterial
Cystic Fibrosis

Interventions: Drug: Cefiderocol

First Posted Date: 2022-04-06

Last Posted Date: 2024-12-16

Lead Sponsor: Hartford Hospital

Target Recruit Count: 10

Registration Number: NCT05314764

Locations: 🇺🇸
Hartford Hospital, Hartford, Connecticut, United States
🇺🇸
IU Health University Hospital, Indianapolis, Indiana, United States
🇺🇸
UPMC Presbyterian Hospital, Pittsburgh, Pennsylvania, United States

and more 1 locations

Cefiderocol PK in Patients on ECMO

Phase 1

Completed

Conditions: Sepsis

Interventions: Drug: Cefiderocol

First Posted Date: 2021-08-09

Last Posted Date: 2024-12-16

Lead Sponsor: Joseph L. Kuti, PharmD

Target Recruit Count: 5

Registration Number: NCT04995835

Locations: 🇺🇸
Hartford Hospital, Hartford, Connecticut, United States
🇺🇸
Columbia University/New York Presbyterian Hospital, New York, New York, United States

A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of Cefiderocol in Hospitalized Pediatric Participants

Phase 2

Completed

Conditions: Hospital Acquired Pneumonia (HAP)
Complicated Urinary Tract Infection (cUTI)
Sepsis
Ventilator-acquired Pneumonia
Bloodstream Infections (BSI)
Complicated Intra-abdominal Infection (cIAI)
Gram-negative Bacterial Infections

Interventions: Drug: Cefiderocol
Drug: Standard of Care

First Posted Date: 2020-04-06

Last Posted Date: 2024-01-24

Lead Sponsor: Shionogi

Target Recruit Count: 54

Registration Number: NCT04335539

Locations: 🇱🇻
Bernu Kliniska Universitates Slimnica Childrens Hospital - Tornakalna, Riga, Latvia
🇪🇪
Tartu Ulikooli Kliinikum - Anestesioloogia ja Intensiivravi Kliinik, Tartu, Estonia
🇬🇪
JSC "Medical Corporation Evex" " M. Iashvili Batumi Maternal and Child Central Hospital", Batumi, Georgia

and more 20 locations

A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Cefiderocol in Hospitalized Pediatric Participants

Phase 2

Completed

Conditions: Hospital Acquired Bacterial Pneumonia (HABP)
Ventilator Associated Bacterial Pneumonia (VABP)
Gram-negative Bacterial Infections
Complicated Urinary Tract Infection (cUTI)

Interventions: Drug: Cefiderocol
Drug: Standard of Care

First Posted Date: 2020-01-02

Last Posted Date: 2024-11-18

Lead Sponsor: Shionogi

Target Recruit Count: 85

Registration Number: NCT04215991

Locations: 🇺🇸
University of Iowa Stead Family Children's Hospital, Iowa City, Iowa, United States
🇬🇪
JSC "EVEX Medical Corporation"- M Lashvili Childrens Central Hospital, Tbilisi, Georgia
🇬🇪
Ltd Unimedi Kakheti Childrens New Clinic, Tbilisi, Georgia

and more 22 locations

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